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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000011057
Receipt No. R000012873
Scientific Title Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Date of disclosure of the study information 2013/07/01
Last modified on 2019/03/29

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Basic information
Public title Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Acronym Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Scientific Title Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Scientific Title:Acronym Study of expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Region
Japan

Condition
Condition Mental retardation
Autistic spectrum disorder
Severe behavioral disorders
Classification by specialty
Psychiatry
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Establish Evidence for making guideline about expert treatment and transition support for people with severe mental retardation and severe behavioral disorders.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes frequency of behavioral disorders
Key secondary outcomes Criteria for severe behabioral disorders
Aberrant Behavior Checklist-Japanese version(total points and subscale of excitability

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom Maneuver
Interventions/Control_1 Behavior therapy and Structualization, and Transition support to facilities or home for patients with severe mental retardation and severe behavioral disorders(2-6months)
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Over 20 points of Criteria for severe behavioral disorders

Over 18 points of Aberrant Behavior Checklist-Japanese,subscale of excitability
Key exclusion criteria Patients with not consent of Guardian of Adult or parents
Target sample size 36

Research contact person
Name of lead principal investigator
1st name Chie
Middle name
Last name Aita
Organization National Hospital Organization Hizen Psychiatric Center
Division name medical office
Zip code 842-0192
Address 160 mitsu yoshinogari saga japan
TEL 0952-52-3231
Email ai-chie@po.bunbun.ne.jp

Public contact
Name of contact person
1st name Chie
Middle name
Last name Aita
Organization National Hospital Organization Hizen Psychiatric Center
Division name medical office
Zip code 842-0192
Address 160 mitsu yoshinogari saga japan
TEL 0952-52-3231
Homepage URL
Email ai-chie@po.bunbun.ne.jp

Sponsor
Institute National Hospital Organization
Institute
Department

Funding Source
Organization National Hospital Organization
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization JAPAN

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization National Hospital Organization Central Ethics Review Committee
Address 2-5-23 Higashigaoka Meguro Tokyo japan
Tel 03-5712-5075
Email kenkyu2004@nho.hosp.go.jp

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 国立病院機構肥前精神医療センター(佐賀県)、賀茂精神医療センター(広島県)、やまと精神医療センター(奈良県)、花巻病院(岩手県)、岩手病院(岩手県)、さいがた病院(新潟県)、北陸病院(富山県)、富山病院(富山県)、小諸高原病院(長野県)、三重病院(三重県)、鈴鹿病院(三重県)、四国こどもとおとなの医療センター(香川県)、菊池病院(熊本県)、琉球病院(沖縄県)

Other administrative information
Date of disclosure of the study information
2013 Year 07 Month 01 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 59
Results
Results date posted
Results Delayed
Delay expected
Results Delay Reason Currently Japanese Journal of Child and Adolescent Psychiatry during final review.
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 05 Month 14 Day
Date of IRB
2013 Year 06 Month 13 Day
Anticipated trial start date
2013 Year 07 Month 01 Day
Last follow-up date
2015 Year 03 Month 31 Day
Date of closure to data entry
2015 Year 03 Month 31 Day
Date trial data considered complete
2015 Year 03 Month 31 Day
Date analysis concluded
2015 Year 12 Month 31 Day

Other
Other related information

Management information
Registered date
2013 Year 06 Month 27 Day
Last modified on
2019 Year 03 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012873

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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